Clinical Trial: Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Colchicine Versus Placebo in Post-Cardiac Surgery Patients to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation
Brief Summary:
The study will determine the benefit of Colchicine versus placebo for cardiac surgery patients on the post-operative development of atrial fibrillation and post-pericardiotomy syndrome.
Primary Objective. Colchicine will reduce the composite endpoint of incidence of post-operative atrial fibrillation and post-pericardiotomy syndrome at 3 months following cardiac surgery.
Secondary Objectives.
- Colchicine will reduce the incidence of constrictive physiology on echocardiography at 3 months following cardiac surgery.
- Reduction in the burden of symptomatic and asymptomatic atrial fibrillation in the 3 months following cardiac surgery with the use of colchicine.
Detailed Summary:
Background. Patients undergoing cardiac surgery are at risk for post-pericardiotomy syndrome and post-operative atrial fibrillation. It is unknown whether post-pericardiotomy syndrome predisposes patients to constrictive pericarditis, but cardiac surgery is currently the most common cause of constrictive pericarditis. A multicenter European study demonstrated that Colchicine is a promising treatment to help prevent the development of pericardial effusions, atrial fibrillation and post-pericardiotomy syndrome (Imazio et al, Circulation 2011;124:2290-5). However, Colchicine is not routinely given to patients after a cardiac surgery and the impact of Colchicine on post-operative atrial fibrillation and constrictive pericarditis have not been studied in the United States.
Methods. This is a randomized, double-blinded placebo controlled study for patients undergoing cardiac surgery to determine if Colchicine in comparison to placebo is effective in preventing the development of post-operative atrial fibrillation, post-pericardiotomy syndrome and constrictive physiology. The investigators will randomize 278 adults prior to undergoing cardiac surgery for CABG or aortic valve disease to receive either placebo or Colchicine 0.6mg bid for one month starting 48-72 hours preoperatively. The investigators will follow participants for 3 months to determine the development of a post-pericardiotomy syndrome. In addition, post-operative atrial fibrillation will be determined based on continuous telemetry from operation up to 5 days prior to hospital discharge and after discharge by using remote telemetry monitoring with BodyGuardianTM. C-reactive protein (CRP) will be obtained prior to hospital discharge and at 3 month follow-up. Echocardiography will be done initially in the post-operative course prior to hospital discharge and then again at 3 months to assess for the presence of pericar
Sponsor: Mayo Clinic
Current Primary Outcome: Number of patients with post cardiac surgery atrial fibrillation or post-pericardiotomy syndrome. [ Time Frame: Baseline to 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Trans-thoracic echocardiography for constriction [ Time Frame: Baseline to 3 months ]
Original Secondary Outcome: Same as current
Information By: Mayo Clinic
Dates:
Date Received: June 18, 2014
Date Started: June 2014
Date Completion:
Last Updated: June 25, 2014
Last Verified: June 2014
